MAUDE Adverse Event Report: COOPERSURGICAL, INC. LL100 MULTI TIP W/TC

Model Number	900629
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currenlty iinvestigating the reported conditon.
Event or Problem Description
Out-of-box failure- the following multi tip freezer of the 900629 appears to be defective.It was recently delivered new to our customer.There is a fault in the frost/defrost valve which prevents proper circulation.Please solve under factory warranty.The product is: 900629 ll100 multi-tip freezer with tc(h20) 2019090004".Incident occurred before procedure.03/23/2021- per update- customer stated- was the instrument not defrosting? answer: during defrosting, the freezing point remains below 0 degrees due to a malfunction in the frost-defrost circulation.Was there patient involvement /how is patient today? answer: yes, but no problems with patient.Any injury or adverse event related? answer: no.Was there any additional medical attention? answer: nurse acted appropriately.No extra attention was needed.What procedure was the physician performing? answer: regular procedure.Appliance kept freezing.Did the physician perform any extra step to complete the procedure / how was the procedure completed? answer: no, it was not necessary.Ll100 multi tip w-tc 900629.E-complaint- (b)(4).
Event or Problem Description
The following multi tip freezer of the 900629 appears to be defective.There is a fault in the frost/defrost valve which prevents proper circulation.Incident occurred before procedure.During defrosting, the freezing point remains below 0 degrees due to a malfunction in the frost-defrost circulation.No problems with patient.No extra attention was needed.1216677-2021-00063-1 ll100 multi tip w tc 900629 (b)(4).
Additional Manufacturer Narrative
Investigation.Review dhr.Inspect returned samples.Analysis and findings.(b)(4).Distribution history: this complaint unit was manufactured at csi on 09/25/2019 under wo #(b)(4) and shipped on 2/12/2021.Manufacturing record review: dhr (b)(4) was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint condition.Product receipt: the complaint unit was returned on rma 316768 on 4/5/2021.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Service & repair confirmed the complaint unit was found with loose brass nuts typically tightened to secure the connection of the tube to the main valve assembly.Root cause: the root cause for this compliant condition is being attributed to assembly error.Correction and/or corrective action.The unit's brass nuts were tightened, then tested to specifications and re-stocked.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.Train personnel.Was the complaint confirmed? yes.

• Brand Name: LL100 MULTI TIP W/TC
• Common Device Name: LL100 MULTI TIP W/TC
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 11628669
• Report Number: 1216677-2021-00063
• Device Sequence Number: 14207021
• Product Code: GEH
• UDI-Device Identifier: 00888937009866
• UDI-Public: 888937009866
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K813024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 900629
• Device Catalogue Number: 900629
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown